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- Title
Safety and efficacy of an olive oil-based triple-chamber bag for parenteral nutrition: a prospective, randomized, multi-center clinical trial in China.
- Authors
Zhen-Yi Jia; Jun Yang; Yang Xia; Da-Nian Tong; Zaloga, Gary P.; Huan-Long Qin; Jia, Zhen-Yi; Yang, Jun; Xia, Yang; Tong, Da-Nian; Qin, Huan-Long; OliClinomel N4 Study Group
- Abstract
<bold>Background: </bold>Small studies suggest differences in efficacy and safety exist between olive oil-based (OLIVE) and soybean oil-based (SOYBEAN) parenteral nutrition regimens in hospitalized adult patients. This large, prospective, randomized (1:1), open-label, multi-center, noninferiority study compared the delivery, efficacy, and safety of OLIVE (N = 226) with SOYBEAN (N = 232) in Chinese adults (≥18 years) admitted to a surgical service for whom parenteral nutrition was required.<bold>Methods: </bold>Treatments were administered for a minimum of 5 days up to 14 days (to achieve approximately 25 kcal/kg/day, 0.9 g/kg/day amino acids, 0.8 g/kg/day lipid). Impact of treatment on anabolic/catabolic and serum inflammatory, chemistry, and hematological markers, safety, and ease of use were assessed. The primary efficacy variable was serum prealbumin level at Day 5.<bold>Results: </bold>OLIVE (n = 219) was not inferior to SOYBEAN (n = 224) based on the prealbumin least square geometric mean [LSGM] ratio [95% CI] 1.12 [1.06, 1.19]; P = 0.002), improved the anabolic/catabolic status of patients enrolled in the study, and was well tolerated compared with SOYBEAN. Improved anabolic status was supported by significantly higher levels of prealbumin at Day 5, albumin at Day 5 and IGF-1 at Day 14 in the OLIVE group, while catabolism was similar between groups. C-reactive protein, intercellular adhesion molecule-1, procalcitonin, and oxidation were similar in each group, but infections were significantly lower with OLIVE (3.6% versus 10.4%; P < 0.01).<bold>Conclusions: </bold>OLIVE provided effective nutrition, was well tolerated, was associated with fewer infections, and conferred greater ease-of-use than SOYBEAN.<bold>Trial Registration: </bold>NTC 01579097.
- Subjects
CHINA; PARENTERAL feeding; OLIVE oil; SOY oil; TRANSTHYRETIN; AMINO acid content of food; ALBUMINS; PARENTERAL feeding equipment; COMPARATIVE studies; INTRAVENOUS fat emulsions; LONGITUDINAL method; RESEARCH methodology; MEDICAL cooperation; RESEARCH; STATISTICAL sampling; EVALUATION research; RANDOMIZED controlled trials; TREATMENT effectiveness; THERAPEUTICS
- Publication
Nutrition Journal, 2015, Vol 14, p1
- ISSN
1475-2891
- Publication type
journal article
- DOI
10.1186/s12937-015-0100-6